QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Abramson Cancer Center at Penn Medicine
Summary
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Women and men age \> 18 years * Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible. * Archival tissue availabl…
Interventions
- Diagnostic TestCE-10-IVD
Leftover tumor tissue from a routine biopsy will be sent for analysis.
Locations (37)
- University of California San Francisco Medical CenterSan Francisco, California
- Smilow Cancer Hospital-Derby Care CenterDerby, Connecticut
- Smilow Cancer Hospital Care CenterFairfield, Connecticut
- Smilow Cancer Hospital at GlastonburyGlastonbury, Connecticut
- Smilow Cancer Hospital Care Center at GreenwichGreenwich, Connecticut
- Smilow Cancer Hospital Care CenterGuilford, Connecticut